Regulatory Affairs Manager III

Company Description eTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50

Job Description

The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. Key Job Activities:

• Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies).
• Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
• Performs scientific writing (e.g. abstracts, manuscripts, presentations).
• Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
• Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates.
• Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
• Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.
• Expert knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices.
• Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
• Performs MAUDE data base reviews
• Communicates with various departments (e.g. Regulatory, Product Development, Clinical Research, Quality) to identify the necessary clinical and technical information.

Qualifications

• This position is located in our corporate offices in Westchester, PA or Raynham, MA or remote (for experience professional).
• Ph.D/Pharm D plus 1 to 2 years of related medical device/drug industry experience (e.g. medical writing, regulatory affairs, clinical research, engineering)
• BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experience Knowledge/Requirements
• Excellent English language skills, especially writing and proofreading.
• Clinical, scientific or research background, highly preferred.
• Experience writing CERs, highly preferred.
• Knowledge in narrative or systematic literature reviews (e.g. PRISMA, Cochrane), highly preferred.
• Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred.
• Expert understanding of scientific or clinical research and methods.
• Understanding of statistical data and good data management practices.
• Strong oral communication, presentation, project management and prioritization skills.
• Excellent interpersonal relationships.
• Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager).

Additional Information Thanks & Regards Neha Sharma Lead Recruiter eTeam Inc – “ACCELERATED HIRES” Efficiency, Synergy, Expertise T-732-248-1900 .Ext 120 Awards #1 Best Places to work in New Jersey-2009,2008,2007,2006 Top Small Diversity Business, 2006 by DiversityBusiness.com Deloitte Technology Fast 500-2007,2006 IMPORTANT NOTE: Under Bills.1618 Title III passed by the 105th U.S. Congress, this email cannot be considered spam as long as it contains our contact information and a link for the removal requests. If you have received this mail in error or prefer not to receive such emails in the future, please reply with "REMOVE" in the subject line and the email id(s) to be removed. All removal requests will be honored ASAP. We sincerely apologize for any inconvenience caused. Apply tot his job Apply To this Job